Food allergens: AOAC draft guidance on immunoassay validation ready for consensus review

The AOAC Gluten & Food Allergens (GFA) Program has recently made available its draft guidance document about Food Allergen Immunoassay Validation. This document aims to provide comprehensive guidelines for method developers conducting validation studies of immunoassay-based food allergen analysis methods.    

The compilation of comments received during the public comment period, along with the program's responses, has been included in the new version of the document. The AOAC GFA Food Allergens program has completed its final review, revision, and reconciliation of these comments, resulting in the "Draft AOAC Food Allergen Immunoassay Validation Guidance 2023 (FINAL)", which is now availability for consensus review.    

These guidelines apply to methods intended for submission for AOAC Official Methods of Analysis (OMA) status, Performance Tested Methods (PTM) certification, or individual method developers conducting single-laboratory validations.
While not specifically aimed at laboratories using commercial immunoassay methods for food allergen analysis, the document can assist these laboratories in understanding consensus-based validation approaches, relevant terminology, and the information expected from method developers.    

The guidance encompasses both quantitative and qualitative food allergen methods, regardless of whether they are proprietary or non-proprietary in nature. This inclusivity ensures that a wide range of methods can be validated using the provided guidelines.    

The AOAC Gluten & Food Allergens community, as well as individuals with a material interest in this field, are invited to participate in the consensus review process. Voting on the draft guidance is open until Friday, December 29. AOAC International encourages the distribution of the document to facilitate broader input and agreement from stakeholders.    



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